CLOMAZOL Vaginal cream Ref.[50650] Active ingredients: Clotrimazole

If the patient has a fever (temperature of 38°C or above), lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal haemorrhage and/or associated shoulder pain the patient should consult a doctor.

Keep the medicine out of reach of children. Avoid contact with eyes. Do not swallow.

Clotrimazole cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms when applied to the genital area (women: intravaginally, labia and adjacent area of the vulva; men: prepuce and glans of the penis).

Clomazol creams contain cetostearyl alcohol: Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels, and similarly with sirolimus. Patients should thus be thoroughly monitored for symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Fertility

No human studies of the effects of clotrimazole on fertility have been performed, however animal studies have not demonstrated any effects of the medicine on fertility.

Pregnancy (Category A)

There is a limited amount of clinical data in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Clotrimazole can be used during pregnancy, but only under the direction of a health care professional.

Lactation

There is no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.

The medication has no or negligible influence on the ability to drive or use machinery.

Frequencies not known. The following adverse reactions have been identified during postapproval use of clotrimazole. Because these reactions are reported voluntarily from a population of uncertain size, frequency cannot be estimated from the available data.

Immune system disorders: Anaphylactic reaction, angioedema, hypersensitivity.

Vascular disorder: Syncope, hypotension

Respiratory, thoracic and mediastinal disorders: Dyspnea

Reproductive system and breast disorders: Vaginal exfoliation, vaginal discharge, vulvovaginal pruritis, vulvovaginal erythema, vulvovaginal discomfort, vulvovaginal burning sensation, vulvovaginal pain, vaginal haemorrhage.

Gastrointestinal disorders: Abdominal pain, nausea.

Skin and subcutaneous tissue disorders: Rash, urticaria

General disorders and administration site conditions: Application site irritation, oedema, pain

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

None known.